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TMCNet:  SAGE Therapeutics Initiates Phase 1/2 Trial of SAGE-547 in Status Epilepticus

[March 27, 2014]

SAGE Therapeutics Initiates Phase 1/2 Trial of SAGE-547 in Status Epilepticus

CAMBRIDGE, Mass. --(Business Wire)--

SAGE Therapeutics, a biopharmaceutical company developing novel medicines to treat life-threatening and rare central nervous system (CNS) disorders, today announced dose initiation of the first patient in a Phase 1/2 clinical trial of SAGE-547, a neuroactive steroid, in super-refractory status epilepticus (SRSE), a critical condition in which the brain is in a state of persistent seizure. The trial is designed to evaluate the safety, tolerability and efficacy of SAGE-547 as an adjunctive therapy for the treatment of SRSE.

"Status epilepticus is a serious condition for which there are limited treatment options. Of the many patients whose condition escalates to refractory or super-refractory status epilepticus, most will not survive or will be discharged from the hospital with significant morbidities," said Stephen Kanes, M.D., Ph.D., chief medical officer of SAGE Therapeutics. "SAGE-547 is supported by strong preclinical data and scientific rationale, and we believe this compound has the potential to reduce or eliminate seizures in these patients who have exhausted all other therapeutic options."

This Phase 1/2 trial is an open label study of SAGE-547 as adjunctive therapy in people with SRSE. The trial is expected to enroll 10 to 15 adult patients with SRSE who have not responded to conventional therapy with continuous intravenous antiepileptic agents and who remain in a state of persistent seizure following one or more weaning attempts from anesthesia. The trial is designed to provide clear data around safety, exposure and the ability of SAGE-547 to effectivly halt SRSE. Electrical brain activity will be evaluated via continuous electroencephalogram (EEG) monitoring before, during and after treatment with SAGE-547. Patients will be administered SAGE-547 intravenously for five days while weaning from anesthesia is attempted and will be monitored for four weeks following treatment.


"This clinical trial exemplifies SAGE's approach to designing studies with well-defined endpoints and development pathways that we believe allow us to make highly informed decisions regarding whether to continue development of our product candidates in an accelerated timeframe," said Jeffrey Jonas, M.D., chief executive officer of SAGE Therapeutics. "Our science and chemistry capabilities are targeting the creation of medicines to treat SE at various stages, and we believe SAGE-547 will be the first of several product candidates for the treatment of seizure disorders. We look forward to further evaluating SAGE-547 for the treatment of this critical and difficult-to-treat CNS condition."

About SAGE-547

SAGE-547 is a potent positive allosteric modulator of both synaptic and extra-synaptic GABAA receptors. GABAA receptors are primary inhibitory neurotransmitters and widely regarded as validated drug targets for a variety of CNS disorders; however, traditional approaches of inhibiting or activating the GABA pathway via synaptic sites only have been associated with significant toxicities. SAGE-547, developed by SAGE Therapeutics using its proprietary chemistry platform, has been shown to modulate both synaptic and extrasynaptic GABAA receptors with high potency and efficacy, and data generated to date show that SAGE-547 has a unique anticonvulsive role in the treatment of status epilepticus.

About Status Epilepticus

Status Epilepticus (SE) is an acute, life-threatening seizure condition that occurs in approximately 150,000 people each year in the U.S.,1 with a mortality rate of nearly 15%. Refractory SE (RSE) occurs in approximately one-third of SE patients for which first and second line treatment options are not effective. These patients are moved to an ICU setting with few treatment options. Currently, there are no approved therapies for RSE. RSE patients that have become refractory to third line therapy and remain in status epilepticus despite continuous intravenous anti-epileptic agents are considered to be in a state of SRSE. Currently, there are no approved therapies for SRSE.

About SAGE Therapeutics

SAGE Therapeutics is a neuroscience-focused company developing medicines to treat life-threatening rare CNS disorders. SAGE's lead program, SAGE-547, is in clinical development for SRSE and is the first of many compounds the company is developing in its portfolio of potential seizure medicines. SAGE's robust chemistry platform has generated multiple new compounds that target the GABAA and NMDA receptors, which have demonstrated preclinical activity. SAGE Therapeutics is a private company launched in 2010 by an experienced team of R&D leaders, CNS experts and investors. For more information, please visit www.sagerx.com.

1 DeLorenzo, Robert J., Pellock, John M., Towne, Alan R., Boggs, Jane G. Epidemiology of Status Epilepticus. J Clin Neuro 1995; 12(4): 316-325.


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